Product News and Recalls

Approval of blood thinner delayed

A report on the Website for ABC’s Channel 13 out of Ohio deals with attempts by Pfizer Inc. and Bristol-Myers Squibb Co. to get federal regulators to approve their experimental anticlotting drug Eliquis.

The U.S. Food and Drug Administration once again delayed that approval, with the agency saying it wants more information on “data management and verification” from a huge international study examining how well Eliquis prevented strokes in patients with an irregular heartbeat called atrial fibrillation.

Eliquis, known chemically as apixaban, is one of a handful of new drugs designed to replace warfarin as the standard treatment for preventing heart attacks and strokes.

The report quotes a research analyst who says there’s a “widespread perception that Eliquis is a best-in-class product” compared to some of the other approved warfarin alternatives.

Boehringer Ingelheim’s Pradaxa, for example, has already been linked to a number of deaths from heart attacks and internal bleeding. There’s no evidence that Pradaxa is safer or more effective than warfarin, and any alleged advantages come from its relative convenience in that it doesn’t require frequent blood testing or rigid dietary restrictions.

And unlike warfarin, Pradaxa has no known antidote for a bleeding emergency.

According to the report, shares for both companies involved in the manufacture of Eliquis dropped since the latest FDA delay. Bristol-Myers shares dropped $1.23, or 3.5 percent, to close at $34.13, and Pfizer shares fell 26 cents, or 1.1 perccent, to $22.47.

The news has a bigger impact on Bristol-Myers, because it is much smaller than Pfizer, the report says.

Patients should consult their doctors before making any changes in their medication. A consultation with a Pradaxa lawyer is also important if there are significant injuries.

See the report here:

http://www.13abc.com/story/18871704/fda-delays-decision-on-pfizer-bristol-myers-drug